Search results for " manufacturing"

Article 2014 Manufacturing Trends and Outlook
In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different …

Article Flexible Facilities for Viral Vector Manufacturing
Yet demand is growing, and flexible and efficient facilities will be needed for multi-product clinical and commercial manufacturing. “In the viral vector space, there is diversity around different…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…ience, at AstraZeneca Biologics to get the latest on performing risk management in biopharmaceutical manufacturing. Risk Assessment Challenges in Biopharma BioPharm: What top challenges do co…

Article Modern Manufacturing Systems Key to FDA Quality Initiative
Agency officials have urged biopharmaceutical manufacturers for more than a decade to adopt more reliable and efficient advanced manufacturing technologies capable of ensuring consistent high-quality …

Article Outsourcing Trends in Biopharmaceutical Manufacturing
According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas…

Article Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
These therapies are fragile and require a complex manufacturing process to produce. For the earliest biologics, patents have expired or are near expiration, opening the door for follow-on generic prod…

Article Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing
This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing. Creating processes that are not only optimal and robust but also economical i…

Article Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s c…

Article Innovative Therapies Require Modern Manufacturing Systems
In developing and bringing to market important new therapies, Jenkins noted, it’s “often manufacturing and inspections that are the rate-limiting steps” for expedited approvals, not clinical developme…

Article Biosimilars to Drive Modern Manufacturing Approaches
And new guidance documents are scheduled on standards for achieving product interchangeability, statistical analytical approaches for documenting product similarity, and managing post-approval manufac…

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